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Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment (CEPELA)

This study has been completed.
Sponsor:
Collaborator:
Given Imaging Ltd.
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00990782
First received: October 6, 2009
Last updated: March 27, 2012
Last verified: March 2012
History of Changes
  Purpose

Patients undergoing radiofrequency ablation (RFA) therapy for atrial fibrillation, can sometimes experience insult or injury to the esophagus, due to the proximity of the esophagus to the RFA treatment area. This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established.


Condition Intervention
Esophageal Lesion
 Device: PillCam ESO Capsule Endoscope

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: CEPELA I Trial: Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • capability of the PillCam ESO 2 capsule endoscope to identify esophageal injury due to RFA therapy for atrial fibrillation [ Time Frame: 24-48 hrs post RFA, and 14 days post-RFA ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • compare patient post-ablation symptoms to esophageal injury findings identified by PillCam ESO capsule endoscope [ Time Frame: 24-48 hrs post-RFA and 14 days post-RFA ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
Single arm - all patients receive capsule endoscopy before and after RFA procedure.
 Device: PillCam ESO Capsule Endoscope
Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic patients with persistent atrial fibrillation selected for radiofrequency ablation
  • Adults aged 18 years and older
  • Patients able to give informed consent

Exclusion Criteria:

  • Patients under the age of 18
  • Patient unable to or unwilling to swallow the capsule endoscopes
  • Patients with cardiac pacemakers, implanted cardiac defibrillators or other implanted electro-medical devices
  • Pregnant or lactating females
  • Subjects with history of abdominal, pelvic, or bowel surgery within the past year
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990782

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Given Imaging Ltd.
Investigators
Principal Investigator: Milan Dodig, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00990782     History of Changes
Other Study ID Numbers: 08-634
Study First Received: October 6, 2009
Last Updated: March 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 22, 2013